FAO Regional Biosafety Program
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- Imogene Harmon
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1 FAO Regional Biosafety Program Core and Biosafety Assessments Prof Stuart D. Blacksell Mahidol-Oxford Tropical Medicine Research Unit (MORU) Bangkok, Thailand. FAO Regional Biosafety Coordinator
2 Laboratory mapping is an essential basis for: Generating reliable and accurate data support the development of strong disease prevention and control systems by indicating the overall functionality of a laboratory Generating a picture of laboratory functionality within and across regions underpinning regional and global approaches to laboratory strengthening Analysing needs indication of the actions required to update and improve the functionality of individual laboratories or of all the laboratories within a region
3 Laboratory mapping is an essential basis for: Helping laboratories to assess their own functionality identify priorities and gaps through comparisons with good practice scenarios Providing a baseline against which objectives can be set and progress monitored Enabling development partners to recognize laboratory functionality and take appropriate and sustainable measures to support the improvement of laboratory capacities
4 FAO CORE Lab Mapping Tool Developed by FAO as a standardised metric to assess laboratory capacity and infrastructure Identifies gaps (opportunities for funding) KPIs for annual assessments Initially developed for vet labs Developed by FAO HQ in 2012 to assess HPAI labs Mia Kim, Pawin Padungtad Beatrice Moulle, Gwenaelle Dauphin & others Cornerstone of FAO regional biosafety program >90 assessments 11 countries >35 labs English, French, Thai, Chinese (more coming soon)
5 FAO Biosafety/Safety Lab Mapping Tool (BLMT) Developed by FAO Assessing biosafety and safety capacity Developers Gwenaelle Dauphin (FAO HQ) Beatrice Mouille (FAO HQ) Sharon Heitela (UC Davis) Stuart Blacksell (MORU/Oxford) Field assessments USDA - ~10 vet labs in Africa (2015) FAO 7 vet labs in Lao, Vietnam, Myanmar ( ) MORU/DTRA 9 hospital labs in Cambodia ( ) FAO/DTRA 12 vet labs in Thailand (2016) FAO 7 vet labs in Vietnam (2016) English, French, Thai, Chinese
6 FAO Lab Mapping Tools Core/Biosafety LMT - "snapshot" view of functionality and evolution over time Lab Country Region Core LMT 5 Areas 17 Categories 108 Questions General Laboratory Profile Infrastructure, equipment, supplies Laboratory Performance Biosafety/Biosecurit y Lab collaboration & networking Geographic location Laboratory Budget Basic supply Organization Infrastructure Equipment Reagent supply Staff skills + availability Sample accession Available technology Training Quality Assurance Biosafety/Biosecurity Staff Security/Health Communication means National lab networking Laboratory collaboration Grand total (%) Lab A Compilation LMT results * for Lab A 01/10/ Self Assessment A 01/10/ Self Assessment B 01/10/ Current assessment C Progress All LMT Results Communication means Staff Security/Health Biosafety/Biosecurity Quality Assurance Laboratory collaboration National lab networking Training Details of all LMT results* for YVDL Available technology Geographic location Laboratory Budget Sample accession Basic supply Organization Infrastructure Equipment Reagent supply Staff skills + availability General laboratory profile Infrastructure, equipment, supplies Lab performance QA, Biosafety/Biosecurity Lab collaboration and networking 11/11/ /10/2014 LMT-BM 4 Areas 20 Categories 97 Questions Area Administration Operational Engineering PPE Category General Personnel Health & Safety Training & Competency Biosafety Manual/ SOPs Good Lab Practices Containment Containment BSL3 Waste Disposal Shipping of Infectious substances Animal facilities Premises Chemical hazard containment Chemical Security Emergencies Fire hazard Electrical BSC General Situation Use of PPE PPE disposal
7 On-site LMT assessment protocols Objective Understand the lab Understand the staff Time 1-2 days Method Meetings with staff Onsite lab visits Output LMT assessments Formal report
8 The LMT Excel file Excel file For each of the 108 subcategories, one out of four options can be selected Scores Scores for the 5 areas, the 18 LMT categories and an overall score will be automatically calculated and graphics generated in the Summary
9 Example LMT Excel file Spider graph Sub-cat summary Area summary
10 Comparing results following baseline LMT assessment Assessment 1 Assessment 2 Assessments Overlaid
11 LMT Mobile application Developed for Core LMT and all LMT modules Android and Apple ios Multi-language support Can see previous assessments and visualize results Can be offline during data collection Sends excel to assessors and FAO portal (voluntary data sharing) Camera integration, pictures can be included for salient points
12 LMT App - Some screenshots Splash screen First launch
13 LMT App - Some screenshots
14 FAO LMT Portal Database compiling all LMT assessments Anonymized results Published by category and subcategory, for national, regional or global view. Laboratory metadata management Assessment and users management Data analysis and reporting National portals available soon
15 FAO Biosafety activities South and South East Asia
16 Laboratory assessments (FAO) mainly Core LMT (44 assessments) Indonesia 10 labs x 2 assessments Lao PDR 1 lab x 3 assessments Cambodia 1 lab x 3 assessments Myanmar 2 lab x 2 assessments Philippines 1 lab x 2 assessments Bangladesh 2 lab x 2 assessments Nepal 1 lab x 2 assessments Bhutan 1 lab x 2 assessments Malaysia 1 lab x 2 assessments Vietnam 2 lab x 2 assessments 2016 (Core and BM-LMT) (17 assessments) Thai DLD DTRA CBEP MORU/NIAH (11 Labs) Vietnam - FAO (4 Labs) Myanmar -FAO (2 Labs) Cambodia - FAO (1 Labs) More to follow (Lao PDR, Cambodia, Nepal, Bangladesh)
17 Core LMT Baseline Study Mean 2012 Mean: % 2012 : 50.1% 2014 : 61.7% Lab Change Highest: +19.8% Lowest : -0.7% Staff skills + availability Staff Security/Health Use of databases/platforms Training Total Available technology 100,0 90,0 80,0 70,0 60,0 50,0 40,0 30,0 20,0 10,0 0,0 Basic supply Mean 2014 Biosafety/Biosecurity Communication means Equipment Geographic location Range 2012 : 24.2%-75.4% 2014 : 26.2%- 79.6% Sample accession Reagent supply Quality Assurance Organization Laboratory collaboration Linkage with satellite labs Infrastructure Laboratory Budget
18 Core LMT Analysis Mean 2012 Strengths Organization Basic Supplies Staff skills and availability Weaknesses <50% Biosafety/Biosecurity Staff security and Health Training Budget Sample accession Range 2012 : 24.2%-75.4% 2014 : 26.2%- 79.6% Mean: % 2012 : 50.1% 2014 : 61.7% Lab Change Highest: +19.8% Lowest : -0.7% Focused development activities Biosafety/Staff health Improvements Biosafety/Biosecurity +16.5% Staff security and Health +21.3% Staff skills + availability Staff Security/Health Use of databases/platforms Training Sample accession Reagent supply Quality Assurance Total Organization Available technology 100,0 90,0 80,0 70,0 60,0 50,0 40,0 30,0 20,0 10,0 0,0 Basic supply Laboratory collaboration Linkage with satellite labs Mean 2014 Biosafety/Biosecurity Communication means Equipment Geographic location Infrastructure Laboratory Budget
19 Core LMT Assessments 2016 Summary Mean SD 18 Labs assessed Mean: 55.5% SD=13% Range: 31% (New Lab) -78% (Nat Ref Lab) Generally low heterogeneity Inter-lab scores (CV:24%) Strengths Organisation Basic supply Weaknesses Training Lab budget LIMS Communication means Staff Security/Health Biosafety/Biosecurity Quality Assurance Laboratory collaboration National lab networking Training Available technology Geographic location 100,0 90,0 80,0 70,0 60,0 50,0 40,0 30,0 20,0 10,0 0,0 Laboratory Budget Sample accession Basic supply Organization Infrastructure Equipment Reagent supply Staff skills + availability
20 Core LMT Assessments 2016 Summary 18 Labs assessed Similar results (pattern) LMIC Country A = 59.4% SD 18% Range: 31% (New Lab) -78% (Nat Ref Lab) Other SEA Labs = 49.0% SD 7% Range: 39%-58% Moderate heterogeneity Inter-lab scores (CV 30%; 14%) Strengths Organisation Basic supply Weaknesses Training Lab budget LIMS Thai labs n=11 Communication means Staff Security/Health Biosafety/Biosec urity Laboratory collaboration National lab networking Quality Assurance Other SEA labs n=7 Training Available technology Geographic location 100,0 90,0 80,0 70,0 60,0 50,0 40,0 30,0 20,0 10,0 0,0 60,0 50,0 40,0 30,0 20,0 10,0 0,0 Laboratory Budget Basic supply Staff skills + availability Sample accession Organization Infrastructure Equipment Reagent supply Geographic location Grand total (%) Lab x 90,0 80,0 Laboratory Budget Laboratory collaboration 70,0 Basic supply National lab networking Communication means Staff Security/Health Biosafety/Biosecurity Quality Assurance Training Sample accession Available technology Organization Infrastructure Equipment Reagent supply Staff skills + availability Mean SD
21 Biosafety LMT Assessments 2016 Summary Summary Mean = 41.3% SD=14% Range: 18% -64% Higher heterogeneity Inter-lab scores (CV 34%) Strengths BSCs PPE disposal Weaknesses (<40%) Personnel H&S Use of PPE Chemical storage and security Electrical Fire hazards Biosafety manuals/sops PPE General situation BSC Electrical Fire hazard Use of PPE Emergencies PPE disposal Chemical Security General 80,0 70,0 60,0 50,0 40,0 30,0 20,0 10,0 0,0 Chemical hazard containment Personnel Health & Safety Premises Training & Competency Biosafety Manual/ SOPs Good Lab Practices Containment Waste Disposal Shipping of Infectious substances Mean SD
22 Biosafety LMT Assessments 2016 Summary Similar results (pattern) LMIC Country A = 61.7% SD 17% Other Regional Labs = 36.8% SD 17% Context relatively OK Variable heterogeneity Inter-lab scores (CV 27%; 46%) Strengths BSCs PPE disposal Weaknesses (<40%) Personnel H&S Use of PPE Chemical storage and security Electrical Fire hazards Biosafety manuals/sops Thai labs General Situation BSC Electrical Fire hazard Other SEA labs PPE General situation Use of PPE Emergencies PPE disposal Chemical Security Overall Score PPE disposal Use of PPE BSC Electrical Fire hazard Emergencies Chemical Security General 80,0 70,0 60,0 50,0 40,0 30,0 20,0 10,0 0,0 Chemical hazard containment General Personnel Health & Safety Training & Competency Biosafety Manual/ SOPs Good Lab Practices Containment Waste Disposal Shipping of Infectious substances Premises Mean Personnel Health & SD Safety Training & Competency Premises Chemical hazard containment Biosafety Manual/ SOPs Good Lab Practices Containment Waste Disposal!Shipping of Infectious substances
23 Waste
24 Special mention Electricals
25 Biosafety Training and Advocacy Team effort-partnership FAO regional biosafety program MORU CDC USAID DTRA-CBEP Classroom-based Basics of biosafety Risk assessment Risk perception Activity-based training PPE Donning and Doffing Respirator fit tests Biosafety Cabinet Certification Biosafety toolbox Activity-based Posters Stickers Manuals
26 Asian LMT training 1 st training Thailand Feb 2016 Trainees 30 Department of livestock development staff Quality/Biosafety 2 nd training Thailand Trainees 25 Regional Vet Lab Biosafety staff
27
28 BSC certification training Training of local staff BSC Certifications BSC Decon/Basic repairs Cambodia Collaboration- CDC, MORU, MoH MORU SMEs Rob Dandy/Marcel Fiocchi Training and technical mentioning NSF 49 Vietnam FAO MORU - RAHO6 BSC ToT 28 Nov-2 Dec 2016
29 BSC Testing Training Online Preparation Module minutes
30 BSC testing results BSC failures Overall failure rate Enrolled since 2012 Number enrolled 46 32,0% 22,5% 23,0% 20,0% 23 17,0% 12,5% 9,0% 15,6% n=130 n=149 n=192 n=162
31 Summary Independent assessment of lab capabilities using LMT Core and Biosafety Identify gaps for future development activities Core Strengths Organization Basic Supplies Staff skills and availability Weaknesses Biosafety/Biosecurity Staff security and Health Training Budget Sample accession Safety/Biosafety Strengths BSCs PPE disposal Weaknesses Personnel H&S Use of PPE Chemical storage and security Electrical Fire hazards Biosafety manuals/sops Weaknesses are focus for future activities
32 Communication between WHO, OIE, FAO, CDC, DTRA, and other stakeholders (One Health approach) is crucial and FAO would like to coordinate with partners to avoid duplication of efforts and look for synergies on capacity building activities on biosafety/biosecurity and occupational health
33 Thank you FAO Rome Lidewij Wiersma Beatrice Moulle Gwenaelle Dauphin Sharon Heitela FAO RAP Bangkok Wantanee Kalpravidh Filip Claes Sanipa Suradhat
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